is Proellex done completely or just shelved because they won't have the money to continue the larger scale trial? If it was so bad why with a larger trial pool? let poison more people? I don't get it. I don't think it's to bad or they wouldn't ask for a larger pool, it's just the red tape. they need to get something to market quickly so the stop bleeding money and can get back to the oral doses later I guess! I believe in the science behind it.
KTOV = Mcap $16 Mil /Cash $17 Mil / ULTRA Low float O/S 10.6 M / NDA submission for potential Blockbuster this Quarter = 20 BAGGER ..ONE OF THE BIGGEST BIOTECH OPPORTUNITY EVER ! Thank me later guys
Kitov Expects to Submit an NDA for KIT-302 in the Third Quarter 2017.Kitov announced that it began the process of compiling the documents necessary to file an NDA for its lead asset KIT-302 as a treatment for patients who experience both osteoarthritis and hypertension. The Company hired Parexel International Corporation, a clinical research organization, to digitalize and formally submit its NDA application. Kitov expects the filing to occur during the third quarter of 2017, with a potential FDA approval during the second quarter of 2018.
KIT-302 is a combination drug that treats osteoarthritis pain and hypertension simultaneously
Primary efficacy endpoint achieved Lead drug candidate KIT-302 achieved its primary efficacy endpoint in a pivotal Phase III trial
Marketing potential Pipeline candidates address large, multi-billion dollar markets
Kitov’s current pipeline products, KIT-301 and KIT-302, are combination drugs that treat OA pain and HTN simultaneously. In December 2015, KIT-302 successfully achieved the primary efficacy endpoint for its Phase III clinical trial. In August 2016, the United States Patent Office issued a patent covering KIT-302.
Of the 27 million Americans with OA, 50% also suffer from HTN, which is also a common side effect of stand-alone OA drugs. With no single medication currently treating both conditions, KIT-301 and KIT-302 are targeting this multi-billion dollar market.
has anyone called that number regarding the investigation?
They got a patent, switched focus to vaginal delivery, and have pending EMA decision approaching. Sounds good
Somebody got a standing order to buy at 38.5 cents. This stock is worth a minimum of 1.25 today. The recent funding dictates this price as they paid for the common share .40 plus .60 for two warrants to purchase more stock at .82 and .94 or somewhere for like a half a share and 3/4 share respectively. Which means to me they value the company some where between 1 dollar and 1.25 a share as of today.
so the waiting continues? being all in at .45- took all my gains and then some, but if the AH price carries through to tmoro won't be such a terrible loss. august 2nd should put it back in the .50' s . still think this is a can't lose price right now. I'm holding!!!
THIS BAD BAD BAD AWFUL AWFIL DISASTER NEWS FROM FDA THIS WILL CRASHCRASHBELOW 20 CENT TO DAY ANDBELOW 10 CENT COMING WEEK TO MONTHS GETOUTOUIT RUN RUN TO THE EXIRTT EXIT DOOR GETOUIT BEFOREVERYONE START TO SELLAND DUMP DUMP THIER SHASRESBELOW 20 CENT TODAY BE VERY VERY AFRAUD TO LOSS ALOT LOT MORE OMNEY TODAY
It's in the same boat as it was Friday...nothing really changed. Hell august 2nd sounds pretty good
HK Op Briefcase
It is a Good Day when you realize your stock is down 40% and instead of selling you buy more... I'm looking for this to bounce back considerably, and when it does I target that it will reach the $0.65-0.80 range in the short term. That's my bold prediction of the week anyway.
Reaction to no change. If anything the EU patent should be good news
dirty move releasing the news hours before the market opens. either the company moved to GUAM, or somebody wanted the hedgies to get their money, but screw the shareholders. shady stuff!
She is a coming back up
Looks bad today but I think it will bounce back in future
Have no choice but to hold now. ouch!
Sell SELL - GET OUT NOW - And while it drops, I will BUY it up FDA yellow tape - just a matter of time.
Let's get .45
I'm just starting my DD for this company. Are there any short term catalysts I should know about. Thanks
Proellex-Right drug, wrong dose. Enclomiphene-Right drug, wrong time. Back in 2008, ex CEO Joe P. was making a case for annual revenue of $3.5 billion (see below) for Proellex. In an effort to prove superior efficacy, they got overzealous and set dosage to high and as a result, liver toxicity. With the stock trading as high as $14 dollars(pre-split), it didn't take long to fall to .28 cents. Fast forward 9 years and Rprx finds itself in third place in the UF/Endo race behind Allergan's Esmya and Abbvie's Elagolix. Both are expected to be up for approval in 2018. While Proellex may ultimately prove to be the best drug, it certainly will not have first mover advantage. Assume only the 700,000 women per year now requiring surgery would seek a drug treatment. Assume the drug would be used ten years, ie, from 39 to 49, to avoid surgery and reach menopause. Assume only 25% of severe case women would opt for pharmaceutical intervention; Assume the annual price of the drug into the market is $1,000 per patient. Then:
Annual Proellex sales for the treatment of Uterine Fibroids in major market countries is $1,750,000,000. That is only the market size for use in firbroid treatments.
Endometriosis is described here.
Podolsky summarizes the market for an effective pharma solution to it as follows:
Potentially, there are 17 million women of reproductive age in the US, Japan, FRance, Germany, Italy, Spain and the U.K. who suffer from endometriosis. If only 10% of those women will seek an effective pharma treatment, at $1,000 per woman annually, the demand is another $1.7 billion.
Even with Joe's shady past and the Proellex setback, somehow he is able to raise money and get the stock moving back up after a 1 for 4 reverse split and the promise of Enclomiphene. Considering the controversy surrounding testosterone, it appeared to be a shoe in for approval because it was not testosterone. The problems with abuse would be eliminated, fertility would be preserved, it wouldn't shut down man's production, instead enhance it, plus it was an oral product. With the stock trading as high as $28 dollars, the Baker Bros and other major funds on board, analyst were flashing the green light. Then came the testosterone adcom and Enclomiphene got sweep down to $8. The FDA wanted more proof of benefits and safety from all T products, which left Rprx with a cancelled adcom and a CRL and a stock price back down to .33 cents. Good news is the EU have a more positive view of testosterone, especially if it benefits the obesity epidemic, plus Proellex is on the verge of coming off clinical hold. Even with all the ups and downs, trials and tribulations, the drugs may still prove to be game changers because the cream always rises to the top, regardless of who is stirring the pot.